Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome

Purpose

This study will evaluate the efficacy and safety of vibegron, a beta-3 adrenergic receptor (β3-AR) agonist, in the treatment of pain associated with irritable bowel syndrome (IBS) due to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation (IBS-M).

Condition

  • Irritable Bowel Syndrome

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of irritable bowel syndrome (IBS) with predominantly diarrhea (IBS-D) or IBS with mixed episodes of diarrhea and constipation (IBS-M) according to the Rome IV criteria - Has completed a colonoscopy according to the American Gastroenterological Association criteria, with no clinically significant findings in the last 5 years - Has no clinically significant findings on a physical examination or clinical laboratory tests that could interfere with study participation or confound study assessments, in the opinion of the Investigator. Serum tissue transglutaminase antibody (IgA) must be negative. Fecal calprotectin testing is optional and should only be considered if there is a strong suspicion that the participant has inflammatory bowel disease (IBD) (eg, family history in a 1st degree relative, other genetic factors, etc.) or other organic disease, according to the clinical judgement of the investigator.

Exclusion Criteria

  • Diagnosis of IBS-C or IBS-U per Rome IV criteria - History of chronic idiopathic constipation or functional constipation - Structural abnormality of the gastrointestinal tract or a disease (e.g., known small intestine bacterial overgrowth) or condition that can affect gastrointestinal motility - History of a gastrointestinal motility disorder other than IBS (e.g., gastroparesis, intestinal pseudo-obstruction, achalasia, Parkinsons disease, multiple sclerosis, spinal cord injury) - Prior history of a gastrointestinal malignancy, inflammatory bowel disease, celiac disease - Planned gastrointestinal or abdominal surgery within the next 6 months - Co-existing gastroesophageal reflux disease or functional dyspepsia with symptoms predominant to IBS symptoms - Symptoms or diagnosis of a medical condition other than IBS that may contribute to abdominal pain (e.g., interstitial cystitis; fibromyalgia currently being treated with pregabalin or gabapentin; and endometriosis with uncontrolled abdominal pain)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Vibegron 75 mg 		Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.
  • Drug: Vibegron
    oral administration
    Other names:
    • RVT-901
    • MK-4618
    • KRP-114V
    • URO-901
Placebo Comparator
Placebo 		Participants will receive matching placebo orally once daily for 12 weeks.
  • Drug: Placebo
    oral administration

More Details

Status
Completed
Sponsor
Urovant Sciences GmbH

Study Contact